G/TBT/N/PHL/280  
11 February 2022  
(22-1215) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  PHILIPPINES   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
DR OSCAR G. GUTIERREZ, JR., MPA  
Officer -in-Charge Director General  
Food and Drug Administration  
DEPARTMENT OF HEALTH  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
MARIA CECILIA C. MATIENZO  
Director IV  
Center for Device Regulation Radiation Health, and Research  
Food and Drug Administration  
DEPARTMENT OF HEALTH  
Email: mccmatienzo@fda.gov.ph ; cdrrhr -prsdd@fda.gov.ph  
www.fda.gov.ph  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  In-Vitro 
Diagnostic Medical Devices (ICS:11.100.10)  
5. Title, number of pages and language(s) of the notified doc ument:  Draft FDA 
Circular entitled "Specific List of Registrable In Vitro Diagnostic Medical Devices (IVDs) 
and Revised Technical Requirements for Registration of COVID -19 Test Kits" (10 page(s), 
in English)  
6. Description of content:  This FDA Circular ai ms to a) provide the specific list of the 
different registrable IVDs based on the capacity of FDA -Common Services Laboratory and 
National Reference Laboratories; and b) provide guidelines on the transition from the 
issuance of Special Certification to Cert ificate of Product Registration for COVID -19 test 
kits and on the revised technical requirements for the registration of COVID -19 test kit 
products.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  G/TBT/N/PHL/280  
 
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  8. Relevant documents:   
• Republic Act No. 9711 and its Implementing Rules and Regulations  
• ASEAN Medical Device Directive (AMDD)  
• FDA Memorandum Circular No. 2014 -005 "Updated List of Medical Devices 
required to be registered prior to sale, distribution and use"  
• FDA Memorandum (FM) No. 2020 -006 "Issuance of Special Certification for 
Imported Test Kits of COVID -19" 
• FDA Memorandum No. 2021 -009 "Minimum Performance Requirements for 
COVID -19 Test Kits Used for SARS -CoV-2 Infection"  
9. Proposed date of adoption:  This Circular shall take effect fifteen (15) days following 
its publication in a newspaper of general circulation and upon filing three (3) certified true 
copies with the University of the Philippines Law Center – Office of the N ational 
Administrative Register.  
Proposed date of entry into force:  This Circular shall take effect fifteen (15) days 
following its publication in a newspaper of general circulation and upon filing three (3) 
certified true copies with the University of th e Philippines Law Center – Office of the 
National Administrative Register.  
10. Final date for comments:  4 March 2022  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
MR. NEIL P. CATAJAY  
Director  
Bureau of Philippine Standards  
Department of Trade and Industry  
3F Trade and Industry Building  
361 Sen. Gil Puyat Avenue  
Makati City, Philippines 1200  
(632) 7751 4700; (632) 7751 4706  
Email: bps@dti.gov.ph   
http://www.bps.dti.gov.ph  
 
https://www.fda.gov.ph/wp -content/uploads/2022/02/Specific -List-of-Registrable -In-
Vitro-Diagnostic -Medical -Devices -IVDs-and-Revis.pdf  
https://members.wto.org/crna ttachments/2022/TBT/PHL/22_1544_00_e.pdf